Clevidipine

What is Clevidipine?

• Clevidipine (Cleviprex) is a dihydropyridine calcium channel blocker used for the reduction of blood pressure when oral therapy is not feasible or not desirable.

Clevidipine

Clevidipine 3D

What are the uses of this medicine?

• Clevidipine (Cleviprex) is used for the reduction of blood pressure when oral therapy is not feasible or not desirable.

How does this medicine work?

• Clevidipine is a dihydropyridine L-type calcium channel blocker.
• L-type calcium channels mediate the influx of calcium during depolarization in arterial smooth muscle.
• Experiments in anesthetized rats and dogs show that clevidipine reduces mean arterial blood pressure by decreasing systemic vascular resistance.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• Allergy to soy or eggs.
• Defective lipid metabolism.
• Severe aortic stenosis.

What drug interactions can this medicine cause?

• The potential of clevidipine to interact with other drugs is low.
• No clinical drug interaction studies were conducted.

Is this medicine FDA approved?

• Initial U.S. Approval: 2008

How should this medicine be used?

• Monitor blood pressure and heart rate during infusion, and until vital signs stabilize.

Recommended dosage:

• Initial dose: Initiate intravenous infusion of Cleviprex at 1- 2 mg/hour.
• Dose titration: Double the dose at short (90 second) intervals initially. As the blood pressure approaches goal, increase the dose by less than doubling and lengthen the time between dose adjustments to every 5-10 minutes. An approximately 1-2 mg/hour increase will generally produce an additional 2-4 mmHg decrease in systolic pressure.
• Maintenance dose: Most patients will achieve the desired therapeutic response at approximately 4-6 mg/hour. Severe hypertension is likely to require higher doses.
• Maximum dose: Most patients have received maximum doses of 16 mg/hour or less. There is limited experience with short-term dosing as high as 32 mg/hour. Because of lipid load restrictions, no more than 1000 mL or an average of 21 mg/hour of Cleviprex infusion is recommended per 24 hour period. There is little experience beyond 72 hours at any dose.

Administration:

• Cleviprex is intended for intravenous use.
• Cleviprex is a single-use parenteral product.
• Do not use if contamination is suspected.
• Once the stopper is punctured, use within 12 hours and discard any unused portion.
• Cleviprex should not be administered in the same line as other medications.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Injectible Emulsion. 50 mL, or 100 mL, or 250 mL. Concentration is 0.5 mg/mL

This medicine is available in fallowing brand namesː

• Cleviprex

What side effects can this medication cause?

The most common side effects of this medicine include:

• headache
• nausea
• vomiting

What special precautions should I follow?

• Use aseptic technique and discard any unused product within 12 hours of stopper puncture.
• Cleviprex may produce systemic hypotension and reflex tachycardia. If either occurs, decrease the dose of Cleviprex.
• Cleviprex contains approximately 0.2 g of lipid per mL (2.0 kcal). Lipid intake restrictions may be necessary for patients with significant disorders of lipid metabolism.
• Dihydropyridine calcium channel blockers can produce negative inotropic effects and exacerbate heart failure. Monitor heart failure patients carefully.
• Cleviprex is not a beta-blocker, does not reduce heart rate, and gives no protection against the effects of abrupt beta-blocker withdrawal. Beta-blockers should be withdrawn only after a gradual reduction in dose.
• Patients who receive prolonged Cleviprex infusions and are not transitioned to other antihypertensive therapies should be monitored for the possibility of rebound hypertension for at least 8 hours after the infusion is stopped.
• There is no information to guide use of Cleviprex in treating hypertension associated with pheochromocytoma.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• hypotension
• reflex tachycardia

Management of overdosage:

• In case of suspected overdosage, Cleviprex should be discontinued immediately and the patient’s blood pressure should be supported.
• Discontinuation of Cleviprex leads to a reduction in antihypertensive effects within 5 to 15 minutes.

Can this medicine be used in pregnancy?

• Pregnancy Category C.
• There are no adequate and well-controlled studies of Cleviprex use in pregnant women.

Can this medicine be used in children?

• The safety and effectiveness of Cleviprex in children under 18 years of age have not been established.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• CLEVIDIPINE

Inactive ingredients:

• SOYBEAN OIL
• GLYCERIN
• EGG PHOSPHOLIPIDS
• OLEIC ACID
• EDETATE DISODIUM
• SODIUM HYDROXIDE

Who manufactures and distributes this medicine?

Manufactured by:

• Fresenius Kabi Austria GmbH, Graz, Austria

Marketed by:

• The Medicines Company
• Parsippany, New Jersey

What should I know about storage and disposal of this medication?

Storage:

• Leave vials in cartons until use. Clevidipine is photosensitive and storage in cartons protects against photodegradation.
• Protection from light during administration is not required.
• Store vials refrigerated at 2-8°C (36-46°F).
• Do not freeze.
• Vials in cartons may be transferred to 25°C (77°F, USP controlled room temperature) for a period not to exceed 2 months.
• Upon transfer to room temperature, mark vials in cartons.
• It must be used or discarded 2 months after this date or the labeled expiration date (whichever date comes first).”
• Do not return to refrigerated storage after beginning room temperature storage.

Handling:

• Maintain aseptic technique while handling Cleviprex.
• Cleviprex is a single-use parenteral product that contains 0.005% disodium edetate to inhibit the rate of growth of microorganisms, for up to 12 hours, in the event of accidental contamination.
• However, Cleviprex can still support the growth of microorganisms, as it is not an antimicrobially preserved product under USP standards.
• Do not use if contamination is suspected.
• Once the stopper is punctured, use within 12 hours and discard any unused portion.
• Cleviprex inhibits microbial growth for up to 12 hours, as demonstrated by test data for representative USP microorganisms, staphylococcus] epidermidis and serratiamarcescens.

• Dailymed label info on Clevidipine
• FDA Clevidipine

Clevidipine Resources
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